FIS 2013, Birmingham

Transcription

1 Fidaxomicin: CDDFT Case Studies Dr Deepa Nayar County Durham and Darlington Foundation Trust FIS 2013, Birmingham This meeting has been initiated and funded by Astellas Pharma Ltd.

2 County Durham and Darlington NHS Foundation Trust (CDDFT) One of the largest hospital and community healthcare providers in the NHS Serves a population of ~600,000 2 Acute sites 6 Community Hospitals Date of This preparation: meeting has November been initiated 2013 and funded by Astellas Pharma Ltd.

3 CDDFT Contractual and upper threshold 2012/2013 Target Actual Acute Community Services 4 6 Total: CDDFT Contractual and upper threshold 2013/2014 Ambition Acute 40 Community Services 4 Total: 44 Date of This preparation: meeting has November been initiated 2013 and funded by Astellas Pharma Ltd.

4 Are we doing everything we can? Trust HCAI reduction group weekly meetings Antimicrobial Stewardship Infection Control Role of fidaxomicin? All C. difficile positive cases reviewed Every case discussed between Microbiologist, infection control, Antibiotic Pharmacists and Clinical team for use of fidaxomicin Reviewed at weekly C. diff MDTs along with a Gastroenterologist until discharge Date of This preparation: meeting has November been initiated 2013 and funded by Astellas Pharma Ltd.

5 Number of Patients Fidaxomicin Between Nov 12 and Sep 13, there were 111 patients with confirmed C. difficile infection across the health economy (74 Community/37 Trust apportioned) 17 cases treated with fidaxomicin Pre 48hr Pre 48hr vs Post 48hr Post 48hr Female Male This meeting has been initiated and funded by Astellas Pharma Ltd.

6 Number of Patients Age range < >80 This meeting has been initiated and funded by Astellas Pharma Ltd.

7 Indication for fidaxomicin and C. difficile severity This meeting has been initiated and funded by Astellas Pharma Ltd.

8 Case Study 1 Date of This preparation: meeting has November been initiated 2013 and funded by Astellas Pharma Ltd.

9 Patient profile and examination Profile 88 year old, Male 57 kg Presenting complaint Shortness of breath, difficulty in swallowing Past medical history COPD Chronic dysphagia Delirium Poor nutritional intake

10 Case history Community acquired pneumonia (CAP), treated with Amoxicillin and Clarithromycin for 7 days Patient then suffered a new cerebro-vascular event and poor swallow on background of chronic dysphagia Need for peg feeding was identified, but family and patient refused in view of Quality of life feeding

11 Ongoing management Hospital stay prolonged by cerebro-vascular event Poor oral intake on background of chronic dysphagia and poor swallow led to recurrent aspirations Another chest infection, treated with IV Tazocin for 7 days Patient suffered loose stools and found to be positive for C. difficile

12 C. difficile management Clinical team referred to Microbiology for treatment of C. difficile, first episode Due to poor swallow, treated with IV Metronidazole and PO Vancomycin for 14 days As high risk of recurrent aspiration and chest infections, PO Vancomycin was continued for 4 more weeks as a tapered, pulsed regime Patient discharged

13 Readmission Aspiration pneumonia treated with IV Tazocin for 7 days After 3 days of IV Tazocin, new onset diarrhoea and was found to be C. difficile positive again Diagnosis: Recurrence of C. difficile infection MDT decision to treat the recurrent episode of C. difficile with fidaxomicin as: Concomitant antibiotics Associated comorbidities Risk of recurrent aspiration and pneumonia

14 Follow-up Patient responded very well to fidaxomicin when he suffered 1 st recurrence of C. difficile infection Patient has been followed up and evaluated since Dec 12 and has had 3 further episodes of chest infections secondary to aspiration He has had 2 further courses of antibiotics for chest infections and 1 hospital admission in the last 7 months Despite these courses, no further recurrence of his diarrhoea

15 Case Study 2 Date of This preparation: meeting has November been initiated 2013 and funded by Astellas Pharma Ltd.

16 Patient profile and examination Profile 43 year old, Female 65 kg Presenting complaint Diarrhoea, Fever, Spontaneous Bacterial Peritonitis (SBP), Sepsis Past medical history Alcoholic Liver Disease, Child C Cirrhosis Recurrent SBP leading to recurrent antibiotics Pancytopenia Recent CDI in past 28 days This meeting has been initiated and funded by Astellas Pharma Ltd.

17 Case history Diagnosed with E. coli septicaemia and SBP on current admission Treated with IV Tazocin for 7 days Diarrhoea on admission, suspected C. difficile on background of recent C. difficile (within last 28 days) C. difficile management MDT decision to treat the recurrent episode of C. difficile with fidaxomicin as: Concomitant antibiotics Associated comorbidities - Pancytopenia, Child C Cirrhosis Risk of recurrent SBP and need for antibiotics This meeting has been initiated and funded by Astellas Pharma Ltd.

18 Follow-up Patient responded very well to fidaxomicin, discharged home diarrhoea free Patient has been followed up and evaluated since April 13 and has had 1 further admission with SBP No further diarrhoea reported, no further stool samples received This meeting has been initiated and funded by Astellas Pharma Ltd.

19 28 day follow up post fidaxomicin This meeting has been initiated and funded by Astellas Pharma Ltd.

20 Follow up End Sep 13 This meeting has been initiated and funded by Astellas Pharma Ltd.

21 What s next? To analyse cost benefit of using fidaxomicin To analyse impact on LOS and bed days To analyse TTROD To develop local guidelines/protocol identifying patients with risk factors for recurrence/relapse EARLY To continue use of fidaxomicin in selected patients and with MDT consensus This meeting has been initiated and funded by Astellas Pharma Ltd.

22 Summary Small numbers Fidaxomicin well tolerated no patients needed to stop course Good clinical response initial data encouraging 3 relapses/recurrences so far 1 confirmed microbiologically, 2 clinical Early recognition of risk factors for relapse/recurrence would help teams find a place for fidaxomicin This meeting has been initiated and funded by Astellas Pharma Ltd.

23 This meeting has been initiated and funded by Astellas Pharma Ltd.

24 Acknowledgements Stuart Brown, Antibiotic Pharmacist Dr D Allison, Dr C Aldridge, Dr L Lim, Dr J Sloss (Microbiologists) Dr A Dhar and Dr D Kejariwal (Gastroenterologists) Tricia Gordon, Lead ICN Mike Wright, DIPC Prof Chris Gray, Medical Director Sue Jacques, CEO, CDDFT This meeting has been initiated and funded by Astellas Pharma Ltd.

25 Questions? DIF13049UKi

26 Thank you Please complete your evaluation forms and hand them in on your way out DIF13049UKi

27 Prescribing Information Dificlir TM (fidaxomicin) Prescribing Information Presentation: Dificlir tablets contain 200 mg fidaxomicin. Indication: The treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. Posology and method of administration: Adults and elderly ( 65 years of age): The recommended dose is one 200 mg tablet to be administered twice daily (once every 12 hours) for 10 days and can be taken with or without food. Paediatrics: The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established. Renal impairment: No dose adjustment is considered necessary. Use with caution in patients with severe renal impairment. Hepatic impairment: No dose adjustment is considered necessary. Use with caution in patients with moderate to severe hepatic impairment. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Hypersensitivity reactions including severe angioedema have been reported. If a severe allergic reaction occurs during treatment with Dificlir, the medicinal product should be discontinued and appropriate measures taken. Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment. Fidaxomicin should also be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI. No data is available in patients with concomitant inflammatory bowel disease, caution should be used in these patients due to a risk of enhanced absorption and a potential risk for systemic adverse reactions. Coadministration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended. Drug interactions: Fidaxomicin is a substrate of P-gp and may be a mild to moderate inhibitor of intestinal P-gp. Co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone are not recommended. Fidaxomicin had a small but not clinically relevant effect on digoxin exposure. However, a larger effect on P-gp substrates with lower bioavailability, more sensitive to intestinal P-gp inhibition, such as dabigatran etexilat, cannot be excluded. Undesirable effects: Common ( 1/100 to < 1/10): vomiting, nausea, constipation. Uncommon ( 1/1,000 to < 1/100): rash, pruritus, decreased appetite, dizziness, headache, dysgeusia, abdominal distension, flatulence, dry mouth, increased alanine aminotransferase. Consult SmPC for complete information on side effects. Packs and Cost: 200 mg tablet x 20 1, Legal Classification: POM. Marketing authorisation number: EU/1/11/733/ Date of Preparation of PI: June Further information available from: Astellas Pharma Ltd, 2000 Hillswood Drive, Chertsey. KT16 0RS. For Medical Information phone: Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Astellas Pharma Ltd. Please contact DIF13049UKi